VP, Regulatory Affairs, Strategy, Labeling and Operations

<div class="content-intro"><p><span style="text-decoration: underline;"><strong><span data-contrast="auto">Mavericks Wanted</span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></span></p> <p><span data-contrast="auto">When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on</span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. </span> <br><span data-contrast="auto"> </span> <br><span data-contrast="auto">Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p></div><h3><strong><u>What You'll Do </u></strong></h3> <p><span style="font-size: 14px;">The Vice President, Regulatory Affairs will <strong>oversee BridgeBio’s Operations and Labeling  functions, and will also support regulatory strategy as needed</strong>. This leader will manage a team of subject matter experts and leaders responsible for Regulatory Operations, Regulatory Business Operations, and Labeling, ensuring excellence, compliance, and strategic alignment across all regulatory activities.</span></p> <p><span style="font-size: 14px;">The VP will ensure the organization has the right infrastructure, technology, and governance to support global submissions, and compliant labeling, while integrating advanced capabilities such as artificial intelligence to drive efficiency and insight.</span></p> <p><span style="font-size: 14px;"><strong>The ideal candidate brings previous broad global regulatory expertise spanning for both development and commercial products, labeling, and operations, combined with understanding and experience in regulatory affairs</strong>, and the ability to lead in a fast-paced, entrepreneurial environment. <span style="color: rgb(236, 240, 241);" data-olk-copy-source="MessageBody">#LI-TC1</span></span></p> <h3><strong><u>Responsibilities</u></strong></h3> <p><strong><span style="font-size: 14px;">Strategic & Functional Leadership</span></strong></p> <ul> <li> <p><span style="font-size: 14px;">Provide overarching leadership and strategic direction for the Regulatory Operations, Regulatory Business Operations, and Labeling, each led by experienced subject matter experts and team leaders</span></p> </li> <li> <p><span style="font-size: 14px;">Partner with the Chief Regulatory Officer and Regulatory Leaders to ensure alignment of operational strategy with regulatory goals</span></p> </li> <li> <p><span style="font-size: 14px;">Foster an infrastructure that enables  innovation, speed, and accountability within and across the regulatory organization</span></p> </li> <li> <p><span style="font-size: 14px;">Lead the integration of artificial intelligence and advanced digital tools across systems and processes to enhance productivity, compliance, and decision-making</span></p> </li> <li> <p><span style="font-size: 14px;">Establish and maintain the framework for regulatory SOPs, work instructions, and desk procedures to ensure consistency, compliance, and clarity</span></p> </li> <li> <p><span style="font-size: 14px;">Lead and develop a team of team leaders and subject matter experts, fostering a collaborative and high-performance culture</span></p> </li> <li> <p><span style="font-size: 14px;">Ensure effective resource planning, talent development, and staff augmentation as needed to support corporate priorities</span></p> </li> <li> <p><span style="font-size: 14px;">Promote continuous learning and professional development within the broader regulatory organization</span></p> </li> </ul> <h3><strong><u>Where You'll Work</u></strong></h3> <p><span style="font-size: 14px;">This is a hybrid role based either in San Francisco, or Washington, D.C. Remote will also be considered.</span></p> <h3><strong><u>Who You Are</u></strong></h3> <ul> <li> <p><span style="font-size: 14px;">Advanced degree in a scientific discipline (PharmD, PhD, MD, or MS) required.</span></p> </li> <li> <p><span style="font-size: 14px;">15+ years of progressive regulatory experience in the biopharmaceutical industry, including leadership of multidisciplinary regulatory teams.</span></p> </li> <li> <p><span style="font-size: 14px;">Proven experience in labeling strategy and operations for development and commercial products, with deep understanding of global submission requirements and post-approval obligations.</span></p> </li> <li> <p><span style="font-size: 14px;">Demonstrated expertise in establishing and managing regulatory systems (e.g., Veeva Vault, RIM) and process governance frameworks (SOPs, WIs, desk procedures).</span></p> </li> <li> <p><span style="font-size: 14px;">Strong working knowledge of clinical and nonclinical regulatory strategy and interactions with global health authorities.</span></p> </li> <li> <p><span style="font-size: 14px;">Track record of leading or enabling digital transformation or AI integration within regulatory or adjacent functions.</span></p> </li> <li> <p><span style="font-size: 14px;">Exceptional leadership, communication, and influencing skills, with the ability to operate effectively in a matrixed, fast-paced environment.</span></p> </li> <li><span style="font-size: 14px;"><span data-olk-copy-source="MessageBody">You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.</span></span></li> </ul> <h3><strong><u>Rewarding Those Who Make the Mission Possible</u></strong></h3> <p>We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. </p> <p><strong>Financial Benefits:</strong></p> <ul> <li> <p>Market leading compensation </p> </li> <li> <p>401K with 100% employer match on first 3% & 50% on the next 2%</p> </li> <li> <p>Employee stock purchase program</p> </li> <li> <p>Pre-tax commuter benefits</p> </li> <li> <p>Referral program with $2,500 award for hired referrals</p> </li> </ul> <p><strong>Health & Wellbeing:</strong></p> <ul> <li> <p>Comprehensive health care with 100% premiums covered - no cost to you and dependents</p> </li> <li> <p>Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)</p> </li> <li> <p>Hybrid work model - employees have the autonomy in where and how they do their work </p> </li> <li> <p>Unlimited flexible paid time off - take the time that you need</p> </li> <li> <p>Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents</p> </li> <li> <p>Flex spending accounts & company-provided group term life & disability </p> </li> <li> <p>Subsidized lunch via Forkable on days worked from our office</p> </li> </ul> <p><strong>Skill Development & Career Paths:</strong></p> <ul> <li> <p>People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility</p> </li> <li> <p>We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching</p> </li> <li> <p>We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities</p> </li> </ul><div class="content-pay-transparency"><div class="pay-input"><div class="description"><div> <div>At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.</div> </div></div><div class="title">Salary</div><div class="pay-range"><span>$345,000</span><span class="divider">—</span><span>$400,000 USD</span></div></div></div><div class="content-conclusion"><p><strong>As a global company, our comprehensive benefits may vary based on location.  <span data-contrast="auto">We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.</span></strong></p> <p><span style="text-decoration: underline;"><strong><span data-contrast="auto">For USA based roles:</span></strong></span></p> <p><strong><span data-contrast="none">Financial & Rewards </span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><strong><span data-contrast="none">Market-leading compensation</span></strong><span data-contrast="none">  </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><strong><span data-contrast="none">401(k) with employer match</span></strong><span data-contrast="none">  </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><strong><span data-contrast="none">Employee Stock Purchase Program (ESPP)</span></strong><span data-contrast="none"> </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><strong><span data-contrast="none">Pre-tax commuter benefits</span></strong><span data-contrast="none"> (transit and parking) </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><strong><span data-contrast="none">Referral bonus</span></strong><span data-contrast="none"> for hired candidates </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="5" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><strong><span data-contrast="none">Subsidized lunch and parking</span></strong><span data-contrast="none"> on in-office days </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p><strong><span data-contrast="none">Health & Well-Being </span></strong><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><strong><span data-contrast="none">100% employer-paid medical, dental, and vision premiums</span></strong><span data-contrast="none"> for you </span><strong><span data-contrast="none">and</span></strong><span data-contrast="none"> your dependents </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><strong><span data-contrast="none">Health Savings Account (HSA)</span></strong><span data-contrast="none"> with annual employer contributions, plus </span><strong><span data-contrast="none">Flexible Spending Accounts (FSA)</span></strong><span data-contrast="none"> </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><strong><span data-contrast="none">Fertility & family-forming benefits</span></strong><span data-contrast="none"> </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none"> </span><strong><span data-contrast="none">Expanded mental health support</span></strong><span data-contrast="none"> (therapy and coaching resources) </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><strong><span data-contrast="none">Hybrid work model</span></strong><span data-contrast="none"> with flexibility </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><strong><span data-contrast="none">Flexible, “take-what-you-need” paid time off</span></strong><span data-contrast="none"> and company-paid holidays </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="6" data-list-defn-props="{"335552541":1,"335559685":1080,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><strong><span data-contrast="none">Comprehensive paid medical and parental leave</span></strong><span data-contrast="none"> to care for yourself and your family </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":240}"> </span></li> </ul> <p><strong><span data-contrast="auto">Skill Development & Career Paths:</span></strong><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities</span><span data-ccp-props="{"134233117":true,"134233118":true,"201341983":0,"335559740":240}"> </span></li> </ul></div>